Table 4

TDI total focal score: treatment comparisons versus placebo for change from baseline at week 6

TDI total focal scorePlaceboPH-797804 dose
0.5 mg3 mg6 mg10 mg
N (baseline)4218446542
Baseline, mean (SD)6.74 (2.20)6.89 (1.64)7.08 (1.92)6.80 (2.14)6.50 (2.38)
N (week 6)4017405840
Adjusted mean change1.5801.0902.5272.5711.443
SE of the mean0.4590.7010.4550.3790.460
95% CI(0.674 to 2.485)(−0.292 to 2.472)(1.630 to 3.424)(1.823 to 3.320)(0.535 to 2.351)
Difference between means*−0.4900.9470.992−0.137
SE of difference*0.8380.6460.5960.650
95% one-sided lower limit for difference*−1.874−0.1210.007−1.212
p Value (difference between means)*0.7200.0720.0490.583
  • *Comparisons are between each dose of PH-797804 and placebo using the full analysis set, which included all patients who were randomised and had a valid FEV1 measurement during the double-blind treatment phase.

  • FEV1, forced expiratory volume in 1 s; TDI, transition dyspnoea index.